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Phenylephrine hydrochloride

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Active ingredient
Phenylephrine Hydrochloride 10 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
September 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 10 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
September 10, 2025
Manufacturer
HHH PHARMA USA LLC
Registration number
M012
NDC root
83586-010
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. It also helps alleviate sinus congestion and pressure, making it easier for you to breathe comfortably. If you're experiencing these symptoms, this drug may provide the relief you need.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms, giving you a sense of comfort and relief. Remember, these effects are temporary, so it's important to follow the recommended guidelines for use.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed. However, make sure not to exceed 6 tablets in a 24-hour period to avoid potential side effects.

For children under 12 years old, it’s important to consult a doctor before giving them this medication. They can provide guidance on the appropriate dosage and ensure it’s safe for your child. Always follow these instructions carefully to ensure safe and effective use of the medication.

What to Avoid

It's important to use this product responsibly. You should never exceed the recommended dose, as doing so can lead to unwanted effects. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, it's always best to follow the guidelines provided to ensure your safety and well-being. If you have any questions or concerns about using this product, please consult with a healthcare professional.

Side Effects

You should be aware of some potential side effects when using this medication. Common reactions may include nervousness, dizziness, or sleeplessness. If you experience any of these symptoms, or if your condition does not improve within 7 days or is accompanied by a fever, it’s important to stop using the medication and consult your doctor.

Additionally, you should avoid this medication if you are currently taking a monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks, as this can lead to serious interactions. If you have any pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, be sure to talk to your doctor before using this product.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

If you suspect an overdose, it is crucial to seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should also stop using this product and call your doctor if you experience nervousness, dizziness, or sleeplessness. Furthermore, if your symptoms do not improve within seven days or if they occur alongside a fever, please reach out to your doctor for further guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it’s important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. Always contact your healthcare provider or local emergency services for guidance in such situations. Remember, it’s better to be cautious and get checked if you think something might be wrong.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is one tablet every four hours, but be sure not to exceed six tablets in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to be cautious when taking certain medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should avoid using this medication. Taking these together can lead to serious interactions that may affect your health.

Always discuss any medications you are taking with your healthcare provider. They can help ensure that your treatments are safe and effective, and they can provide guidance on any potential interactions with other drugs or tests. Your safety is the top priority, so don't hesitate to ask questions about your medications.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20°-25°C (68°-77°F). It's important to keep it away from excessive moisture, as this can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and disposal.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. If the patient is under 12 years old, consult a doctor for appropriate dosing.

If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this medication. Always keep it out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

What is the recommended dosage for adults and children 12 years and over?

Adults and children 12 years and over should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours.

What should children under 12 years do before using this drug?

Children under 12 years should ask a doctor before use.

Are there any contraindications for this drug?

No specific contraindications are mentioned, but do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience nervousness, dizziness, or sleeplessness?

Stop using the drug and ask a doctor if you experience nervousness, dizziness, or sleeplessness.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center at 1-800 222-1222 immediately.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this drug.

How should I store this drug?

Store the drug at controlled room temperature between 20°-25°C (68°-77°F) and protect it from excessive moisture.

Packaging Info

Below are the non-prescription pack sizes of Phenylephrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hydrochloride.
Details

Drug Information (PDF)

This file contains official product information for Phenylephrine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 1 tablet every 4 hours as needed. The maximum allowable dosage is 6 tablets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose may lead to adverse effects.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

In the event of an overdose, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by a fever, it is essential to stop taking the product and seek medical advice.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs) for depression, psychiatric or emotional conditions, or Parkinson's disease. The use of this product is contraindicated in patients currently taking an MAOI or within 2 weeks of discontinuing such medication. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions that warrant discontinuation of the product and consultation with a healthcare provider include nervousness, dizziness, and sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, patients should seek medical advice.

Before using this product, patients with pre-existing conditions should consult a healthcare professional if they have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on an MAOI or for a period of two weeks following the discontinuation of an MAOI. The combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, routine monitoring or dosage adjustments are not necessary for other medications or tests unless otherwise specified in clinical practice.

Packaging & NDC

Below are the non-prescription pack sizes of Phenylephrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hydrochloride.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory depression, or other neurological manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or toxicology specialist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if symptoms do not improve within 7 days or if they occur alongside a fever.

It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it while using this product. Furthermore, patients should be encouraged to consult a doctor prior to use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature, maintained between 20°-25°C (68°-77°F). Care must be taken to protect the product from excessive moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours, with a maximum of six tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Phenylephrine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Phenylephrine Hydrochloride, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.